FDA Cigar Warning Rule Vacated Following Industry Win on Appeal

The FDA must start over with a rule requiring extensive health warnings on cigar and pipe tobacco packaging and advertisements because vacating an invalid rule is the usual course, a federal court in the District of Columbia said Friday.

An appeals court held in July that the U.S. Food and Drug Administration skipped a necessary step in crafting the rule. The correct remedy is to vacate the rule, not simply send it back to the agency, Judge Amit P. Mehta said for the U.S. District Court for the District of Columbia.

At issue is a rule “deeming” certain products to be “tobacco products” subject to the FDA’s authority.

When the FDA imposes warning requirements for tobacco products, the Federal Food, Drug, and Cosmetic Act mandates that it consider cessation and adoption rates, the appeals court said in July.. The FDA didn’t do so, the appeals court said.

Two factors can allow an agency to avoid having an invalid rule vacated, but neither is present here, Mehta said. The rule has “serious deficiencies,” he said. And vacating it wouldn’t be disruptive because its requirements haven’t gone into effect, he said.

Mehta’s order vacated only the warning requirements for cigars and pipe tobacco.

Mehta has also been handling challenges to FDA action on premium cigars. He said in February that the FDA didn’t provide a reasonable explanation why it subjected premium cigars to the same warning requirements as mass-market cigars. And in August, he allowed some aspects of the rule imposing premarket review requirements on premium cigars but said it had to consider a more streamlined process.

Steptoe & Johnson LLP, Goodwin Procter LLP, and Norton Rose Fulbright US LLP represented the Cigar Association of America and other associations challenging the rule. DOJ represented the FDA.

The case is Cigar Ass’n of Am. v. FDA, D.D.C., No. 1:16-cv-01460, 9/11/20.